CSV Engineer

NES Global Talent
United Kingdom
£40000 - £60000 per annum, Benefits Excellent Benefits
30 Sep 2017
05 Nov 2017
Contract Type
Full Time
Computerised Systems Validation Engineer – Medical Devices - Permanent – East Anglia

My client is currently searching for a Computerised Systems Validation Engineer. The role is responsible for writing, executing and reporting CSV activities within the framework of cGMP. You will be responsible for multiple validation projects and liaising with wider project teams. You must be fully conversant and trained in EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5.

As a Computerised Systems Validation Engineer, you will;

  • Define, risk based validation approach for new and changes to existing systems.
  • Lead and execute computerised systems validation activities on site including defining the validation requirements and ensuring systems compliance to EU GMP Annex 11, 21 CFR Part 11, GAMP 5, along with the continuous regulatory expectations.
  • Train staff in computerised systems validation procedures and principles during execution activities.
  • Identify, develop and maintain stakeholder relationships.
  • Conduct and support audits of internal systems and suppliers.
  • Maintain up to date knowledge of related regulations and best practices.
  • Report directly into the Validation Manager.

In order to be successful in applying for the role of Computerised Systems Validation Engineer, you will be / have:

  • Educated to degree level or equivalent in science or engineering subject or 5 to 10 years of experience in the medical device/pharmaceutical industry conducting software validation.
  • Detailed understanding of GMP, Quality Assurance and documentation systems in a pharmaceutical environment.
  • Significant experience in the validation of regulated computer systems applications and infrastructure (e.g SAP, LIMS, MES, SCADA etc).
  • Excellent communication and inter-personal skills, to enable the job holder to inspire/motivate colleagues, support other areas and influence at a senior level.
  • Ability to work in a multidisciplinary team at all levels.
Established in 1978, NES Global Talent provides a complete range of contract and permanent talent solutions to the Oil and Gas, Power, Construction and Infrastructure, Life Sciences, Manufacturing and IT sectors worldwide. With more than 40 offices in 28 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. Offering far more than a traditional recruitment service, we fully support our contractors while they are on assignment with everything from securing visas and work permits, to providing market leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
This job was originally posted as www.totaljobs.com/job/76645893